MSI is a molecular indicator of defective DNA mismatch repair (dMMR). The MSI/dMMR status is observed in all tumor types, representing notably 5% of metastatic colorectal cancers (mCRC), 25% of advanced endometrial cancer and 8% of metastatic gastric cancer.
MSI/dMMR cancers are highly immunogenic. MSI/dMMR tumors are characterized by a high tumor mutational burden with highly immunogenic neoantigens. These tumors are associated with an upregulation of immune checkpoints (PD1, PDL1, CTLA4, etc.) that protects MSI cancer cells from their hostile immune micro-environment, characterized by a high infiltration of activated cytotoxic T CD8+ and NK lymphocytes. Consequently, MSI/dMMR cancers are highly sensitive to ICIs, whatever the tumor location. MSI/dMMR status is a predictive biomarker for the efficacy of immunotherapy, regardless of the tumor type. Then, by several phase II and III studies The efficacy of immunotherapy has been demonstrated as front-line treatment for patients with chemotherapy-naive MSI/dMMR mCRC and gastric cancer. The phase III KEYNOTE-177 trial evaluating first-line treatment of pembrolizumab in patients with MSI/dMMR mCRC demonstrated its superiority over first-line chemotherapy, with a significant improvement of health-related quality of life. At final analysis, the median follow-up was 44.5 months. Median PFS was 16.5 versus 8.2 months (HR = 0.59; 95%CI 0.45-0.79). The hazard ratio favored pembrolizumab versus chemotherapy with a trend toward reduction in the risk of death (HR 0.74; 95% CI, 0.53-1.03; P=0.0359), despite a 60% effective crossover rate. Pembrolizumab has been approved by the FDA and the EMA for patients with newly diagnosed MSI/dMMR mCRC and is now the standard of care for this population. Also, the phase III CHECKMATE-649 trial reveal that the Combination of immunotherapy and cytotoxic chemotherapy is the new standard of care for patients with newly diagnosed metastatic oesogastric cancer. Importantly, results of the CHECKMATE-649 are outstanding for the subgroup population of MSI/dMMR gastric cancer patients (N = 44). Indeed, the unstratified hazard ratio for OS with nivolumab plus chemotherapy versus chemotherapy alone was 0.33 (95% CI 0.12-0.87) for patients with MSI/dMMR tumors. All in all, ICIs are the standard of care in first-line setting for patients with mCRC or metastatic oesogastric cancer. Besides, several phase II studies suggest that ICI combinations might overcome primary resistance to anti-PD1 monotherapy These data justify the development of bispecific monoclonal antibodies targeting both PD1 and CTLA4 such as MEDI5752. MEDI5752 has been developed based on the observation that there is a higher expression of PD-1/CTLA-4 on tumor resident versus peripheral T cells. Preclinical data show MEDI5752 fully suppresses PD-1 and preferentially inhibits CTLA-4 in the tumor versus the periphery, which is meant to uncouple CTLA-4 dependant peripheral toxicity from antitumor activity Natural killer cells are integral to the functioning of the innate immune system and play an important role in innate antitumor immunity. There is a growing body of evidence for targeting the NKG2A/HLA-E axis in combination with other ICIs to sensitize tumors to ICI therapy. NKG2A recognizes the non-classical HLA class I molecule HLA-E. The NKG2A receptor is found on peripheral NK cells and subsets of T cells in cancer patients. It is also present in tumor-infiltrating NK and cytotoxic T cells. Importantly, NK cells and the NKG2A/HLA-E axis play a crucial role in MSI/dMMR tumors. Therefore, a combined blockade of non-redundant checkpoint pathways to unleash NK and T cells seems particularly promising for MSI/dMMR neoplasms. Monalizumab specifically binds and blocks the inhibitory receptor NKG2A. Monalizumab has been investigated in combination with ibrutinib (in chronic lymphoid leukemia), cetuximab +/- durvalumab (in squamous cell carcinoma of the head and neck, and in solid tumors), durvalumab +/- FOLFOX (in solid tumors). In the first-in-human dose escalation of monalizumab plus durvalumab, a manageable toxicity profile was shown.
Taken together, these data provide a strong rational to combine an inhibitor of the NKG2A/HLA-E axis with a bispecific monoclonal antibody targeting both PD1 and CTLA4 for patients with metastatic MSI/dMMR cancers.

Start Date01 Dec 2023

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

NCT05903092 / RecruitingPhase 2

A Phase II Trial of MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer (MOZART)

The study treatment will consist of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide plus durvalumab plus monalizumab every 3 weeks for 4 cycles. After 4 cycles, subjects will continue maintenance treatment with durvalumab plus monalizumab every 4 weeks until disease progression, unacceptable toxicity, decision to stop study treatment, or withdrawal of consent. Patients who have received one prior cycle of treatment before enrolling on the study will receive a total of 4 cycles with monalizumab, durvalumab, and chemotherapy. There will be a safety lead-in phase, including 6 to 12 patients, to confirm the safety of the proposed dose of monalizumab to use in combination with chemotherapy and durvalumab.

Start Date26 Sep 2023

Sponsor / Collaborator

Hoosier Cancer Research Network

[+2]

CTR20221537 / RecruitingPhase 3

一项评价度伐利尤单抗 + Oleclumab和度伐利尤单抗 + Monalizumab用于根治性含铂药物同步放化疗后未进展的局部晚期（III期）、不可切除非小细胞肺癌（NSCLC）患者的双盲、安慰剂对照、随机、多中心、国际、III期研究（PACIFIC-9）

[Translation] A double-blind, placebo-controlled, randomized, multicenter, international, phase III study evaluating durvalumab plus oleclumab versus durvalumab plus monalizumab in patients with locally advanced (stage III), unresectable non-small cell lung cancer (NSCLC) who have not progressed after definitive platinum-based concurrent chemoradiotherapy (PACIFIC-9)

主要目的旨在为证明在既往含铂cCRT治疗后未发生疾病进展的不可切除III期NSCLC受试者中度伐利尤单抗 + Oleclumab优效于度伐利尤单抗 + 安慰剂; 以及证明在既往含铂cCRT治疗后未发生疾病进展的不可切除III期NSCLC受试者中度伐利尤单抗 + Monalizumab优效于度伐利尤单抗 + 安慰剂。

[Translation]

The primary objectives are to demonstrate the superiority of durvalumab + oleclumab over durvalumab + placebo in subjects with unresectable stage III NSCLC who have not had disease progression after prior platinum-based cCRT; and to demonstrate the superiority of durvalumab + monalizumab over durvalumab + placebo in subjects with unresectable stage III NSCLC who have not had disease progression after prior platinum-based cCRT.

Start Date15 Aug 2022

Sponsor / Collaborator

AstraZeneca Global R&D (China) Co., Ltd.

[+2]

100 Clinical Results associated with Monalizumab

100 Translational Medicine associated with Monalizumab

100 Patents (Medical) associated with Monalizumab

Literatures (Medical) associated with Monalizumab

01 Nov 2023·Cancer discovery

Neoadjuvant Durvalumab Alone or Combined with Novel Immuno-Oncology Agents in Resectable Lung Cancer: The Phase II NeoCOAST Platform Trial

Article

Author: Yau, Edwin H ; Sellman, Bret R ; Weder, Walter ; Kar, Gozde ; Hamid, Oday ; Spicer, Jonathan D ; García-Campelo, Rosario ; Soo-Hoo, Yee ; Tan, Tze Heng ; Cascone, Tina ; Mager, Raymond ; McGrath, Lara ; Spira, Alexander I ; Daniel, Davey B ; Rodriguez-Canales, Jaime ; Forde, Patrick M ; Cheng, Lin-Yang ; Grenga, Italia ; Anagnostou, Valsamo ; Surace, Michael ; Zheng, Ying ; Spigel, David R ; Kumar, Rakesh ; Gopalakrishnan, Vancheswaran ; Hussein, Maen ; Mazieres, Julien ; Blando, Jorge ; Oliveira, Julio

Abstract:

Neoadjuvant chemoimmunotherapy improves pathologic complete response rate and event-free survival in patients with resectable non–small cell lung cancer (NSCLC) versus chemotherapy alone. NeoCOAST was the first randomized, multidrug platform trial to examine novel neoadjuvant immuno-oncology combinations for patients with resectable NSCLC, using major pathologic response (MPR) rate as the primary endpoint. Eighty-three patients received a single cycle of treatment: 26 received durvalumab (anti–PD-L1) monotherapy, 21 received durvalumab plus oleclumab (anti-CD73), 20 received durvalumab plus monalizumab (anti-NKG2A), and 16 received durvalumab plus danvatirsen (anti-STAT3 antisense oligonucleotide). MPR rates were higher for patients in the combination arms versus durvalumab alone. Safety profiles for the combinations were similar to those of durvalumab alone. Multiplatform immune profiling suggested that improved MPR rates in the durvalumab plus oleclumab and durvalumab plus monalizumab arms were associated with enhanced effector immune infiltration of tumors, interferon responses and markers of tertiary lymphoid structure formation, and systemic functional immune cell activation.

Significance::

A neoadjuvant platform trial can rapidly generate clinical and translational data using candidate surrogate endpoints like MPR. In NeoCOAST, patients with resectable NSCLC had improved MPR rates after durvalumab plus oleclumab or monalizumab versus durvalumab alone and tumoral transcriptomic signatures indicative of augmented immune cell activation and function.See related commentary by Cooper and Yu, p. 2306.This article is featured in Selected Articles from This Issue, p. 2293

01 May 2024·Combinatorial chemistry & high throughput screening

A Novel Natural Killer Cell-related Gene Signature for Improving the Prediction of Prognosis and Immunotherapy Response in Bladder Cancer

Article

Author: Yang, Guanghua ; Li, Shuai ; Wei, Xifeng ; Liu, Ranlu ; Ma, Xudong

Background::

Bladder cancer (BLCA) is a commonly diagnosed cancer worldwide that exhibits high rates of recurrence and metastasis. Immunotherapy is increasingly being recognised in the clinical management of bladder cancer. In addition, the prospect of developing Natural Killer (NK) cell-related immunotherapy is promising in BLCA.

Methods::

We established and verified a prognostic signature based on NK cell-related gene expression. We then calculated the NKscore of BLCA samples and correlated it with the clinical outcomes, molecular subtypes of BLCA, tumour microenvironment (TME), and predicted efficacy of immune checkpoint inhibitors (ICI) and chemotherapy drugs to thoroughly explore the implications of the NKscore. Finally, the role of the NK signature gene HECTD1 in BLCA was verified by Quantitative Real-time PCR, Cell Counting Kit-8 Assay (CCK-8), Transwell Assay and Colony Formation Experiment.

Results::

We analysed NK cell-associated genes and identified six genes with significant prognostic relevance. A high NK score significantly represents a worse prognosis. NKscore was significantly correlated with seven types of classical molecular subtype classifications of BLCA. In addition, NKscore positively correlates with NK-related immune checkpoints, suggesting that emerging NK cell immune checkpoint inhibitors, such as monalizumab, may have potential therapeutic promise for patients with high NKscore. The results of the T cell inflamed score (TIS) and tumour immune dysfunction exclusion (TIDE) score confirmed the suitability of immunotherapy for patients with a high NK score. Likewise, patients with a high NK score may be more suitable for several significant chemotherapeutic drugs. Functional experiments showed that the knockdown of HECTD1 significantly attenuated the proliferation, migration, and invasion ability of tumour cells.

Conclusion::

To sum up, the capability of our signature to predict prognosis and immunotherapy response was robust. Hopefully, these results will provide new insights for BLCA research and patient immunotherapy.

01 Aug 2023·Current oncology reports

Immunotherapy in Head and Neck Cancer: Where Do We Stand?

Review

Author: Vallianou, Natalia G ; Panagopoulos, Fotis ; Evangelopoulos, Angelos ; Stratigou, Theodora ; Karampela, Irene ; Kounatidis, Dimitris ; Dalamaga, Maria ; Geladari, Eleni

PURPOSEOF REVIEW:

Head and neck cancer (HNC) comprises a group of malignancies, amongst which squamous cell carcinoma accounts for more than 90% of the cases. HNC has been related to tobacco use, alcohol consumption, human papillomavirus, Epstein-Barr virus, air pollution, and previous local radiotherapy. HNC has been associated with substantial morbidity and mortality. This review aims to summarize the recent findings regarding immunotherapy in HNC.

RECENT FINDINGS:

The recent introduction of immunotherapy, with the use of programmed death 1 (PD-1) inhibitors pembrolizumab and nivolumab, which have been FDA approved for the treatment of metastatic or recurrent head and neck squamous cell carcinoma, has changed the field in metastatic or recurrent disease. There are many ongoing trials regarding the use of novel immunotherapeutic agents, such as durvalumab, atezolizumab, avelumab, tremelimumab, and monalizumab. In this review, we focus on the therapeutic potential of novel immunotherapy treatment modalities, such as combinations of newer immune-checkpoint inhibitors; the use of tumor vaccines such as human papillomavirus-targeted vaccines; the potential use of oncolytic viruses; as well as the latest advances regarding adoptive cellular immunotherapy. As novel treatment options are still emerging, a more personalized approach to metastatic or recurrent HNC therapy should be followed. Moreover, the role of the microbiome in immunotherapy, the limitations of immunotherapy, and the various diagnostic, prognostic, and predictive biomarkers based on genetics and the tumor microenvironment are synopsized.

News (Medical) associated with Monalizumab

17 Jun 2024

·pipelinereview.com

Innate Pharma Shares Updated Results From the Sanofi Developed Blood Cancer Phase 1/2 SAR443579/IPH6101 Trial

MARSEILLE, France I June 17, 2024 I Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) announced today that updated efficacy and safety results from the dose-escalation part of the Phase 1/2 study with SAR443579/IPH6101 (SAR’579), an investigational CD123 targeting NKp46/CD16-based Natural Killer Cell Engager (NKCE), from a joint research collaboration between Innate Pharma and Sanofi and ANKET ® platform lead asset, were shared in an oral presentation at the European Hematology Association 2024 Congress in Madrid, Spain on Sunday, June 16 at 11:45 CEST. The study, led by Sanofi, tests SAR’579 as a monotherapy for the treatment of blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia (R/R AML), B‑cell acute lymphoblastic leukemia (B-ALL) and high-risk myelodysplasia (HR-MDS). SAR’579 has FDA Fast Track Designation for the treatment of acute myeloid leukemia. “ We are pleased to see that SAR’579 continues to show promising and durable clinical efficacy along with a favorable safety profile. The ongoing Phase 1/2 study has recently progressed to the Phase 2 stage, marking a significant milestone in its development. We look forward to the continued progress of this multi-specific NK Cell Engager which holds great potential to benefit patients suffering from various blood cancers , ” says Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma . Fifty-nine patients (58 R/R AML and 1 HR-MDS) across 11 dose levels (0.01 – 6mg/kg) were treated. Patients had received a median of 2 (1 – 10) prior lines of treatment. A maximum response rate was observed at a final target dose of 1 mg/kg every week with 5 AML patients achieving a CR (4 CR/1 CRi) 1 . The median treatment duration was 7.9 weeks, with durable CR (>10 months) observed in 3 patients with 2 remaining on maintenance therapy as of the data cutoff. SAR’579 was well tolerated up to doses of 6 mg/kg every week. These data will form the basis for selection of recommended doses for development in the Phase 2 portion of the trial. “ We are excited about the emerging results from our development of SAR’579. Ongoing studies are focused on further demonstrating the potential of the NK cell engager in patients with leukemia. We look forward to sharing data from these trials at future scientific meetings,” says Peter Adamson, Global Development Head, Oncology, Sanofi . About ANKET ® ANKET ® (Antibody-based NKcell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. About the Innate-Sanofi research collaboration and licensing agreements The Company has a research collaboration and license agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells. Under the terms of the 2016 research collaboration and license agreement , Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes SAR443579/IPH6101 (Trifunctional anti-CD123 NKp46xCD16 NK cell engager) and SAR445514/IPH6401 (Trifunctional anti-BCMA NKp46xCD16 NK cell engager). As part of the 2016 agreement, Innate Pharma is eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales. As part of the license agreement entered in December 2022 , Sanofi licensed IPH62 and IPH67 and has the option for one additional target. Under the terms of the 2022 agreement, Innate Pharma is eligible to up to €1.35bn in development and commercial milestone payments as well as royalties on net sales. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET ® ( A ntibody-based NK cell E ngager T herapeutics) proprietary platform. Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET ® multi-specific NK cell engagers to address multiple tumor types. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X . 1 CR: complete remission; CRi: CR with incomplete hematological recovery SOURCE: Innate Pharma

Phase 2Clinical ResultLicense out/inImmunotherapyFast Track

04 Jun 2024

·www.biospace.com

Innate Pharma Presents Positive Results From TELLOMAK Phase 2 Study With Lacutamab in Mycosis Fungoides

In heavily pretreated patients with mycosis fungoides, treatment with lacutamab results in meaningful anti-tumor activity regardless of baseline KIR3DL2 expression level. Lacutamab was well-tolerated with a safety pro with prior studies. Innate will host a virtual KOL event on Tuesday, June 11, 2024 at 4:00PM CEST (10:00AM EDT). MARSEILLE, France--(BUSINESS WIRE)-- Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) announced favorable results from the Phase 2 TELLOMAK study with lacutamab in mycosis fungoides (MF). The results were presented at the ASCO 2024 Annual Meeting, in Chicago, Illinois. As of October 13, 2023, data cutoff, MF patients (n=107) received a median of 4 prior systemic therapies and had a median follow-up of 11.8 months. The data demonstrate that treatment with lacutamab resulted in meaningful antitumor activity, regardless of the KIR3DL2 baseline expression, and an overall favorable safety profile. The global objective response rate (ORR) was 16.8% (Olsen 2011) and 22.4% (Olsen 2022), including 2 complete responses (CR) and 16 partial responses (PR). In patients expressing a baseline KIR3DL2 ≥ 1%, the ORR was 20.8% (Olsen 2011) and 29.2% (Olsen 2022). Median progression-free survival was 10.2 months (95% CI 6.5, 16.8) for all MF patients and 12.0 months (95% CI 5.6, 20.0) in the KIR3DL2 ≥ 1% group. Time to response was 1.0 month (95% CI 1, 5). “The anti-tumor activity observed in the Phase 2 TELLOMAK trial confirms that treatment with lacutamab achieves clinically meaningful outcomes for heavily pretreated patients with mycosis fungoides regardless of baseline KIR3DL2 expression level,” commented Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma. “These results are very promising, considering the number of prior systemic therapies that the patients had received before, and the lack of available drugs. These data support further development of lacutamab to bring improved treatments to patients with cutaneous T cell lymphomas.” Prof. Pierluigi Porcu, Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, Jefferson Health, Philadelphia, and Principal Investigator in the TELLOMAK study, added: “Mycosis fungoides patients have few efficacious and safe therapeutic options at advanced stages. It is promising to see lacutamab achieving remarkable efficacy along with excellent tolerability in this heavily pre-treated population. We express our gratitude to the investigators, clinical research coordinators, patients and caregivers involved in the TELLOMAK program.” Efficacy in MF patients and according to KIR3DL2 subgroup ITT set All MF N=107 KIR3DL2 ≥ 1% N=48 KIR3DL2 <1% N=59 Olsen 2011 Global ORR % (95%CI) 16.8% (10.9, 25.0) 20.8% (11.7, 34.3) 13.6% (7.0, 24.5) Olsen 2022 Global ORR % (95%CI) 22.4% (15.6, 31.2) 29.2% (18.2, 43.2) 16.9% (9.5, 28.5) CR n (%) 2 (1.9) 2 (4.2) 0 (0.0) PR n (%) 16 (15.0) 8 (16.7) 8 (13.6) SD1 n (%) 74 (69.2) 30 (62.5) 44 (74.6) PD n (%) 13 (12.1) 6 (12.5) 7 (11.9) NE n (%) 2 (1.9) 2 (4.2) 0 (0.0) Time to global response (mo) median (range) 1.0 (1-5) 1.0 (1-5) 1.9 (1-4) Skin response (n=107) % (95%CI) 29.0% (21.2;38.2) 33.3% (21.7;47.5) 25.4% (16.1;37.8) PFS (months) median (95%CI) 10.2 (6.5, 16.8) 12.0 (5.6, 20.0) 8.5 (6.5, 17.5) Virtual KOL Event Details Tuesday, June 11, 2024 at 4:00PM CEST (9:00AM EDT) The live webcast will be available at the following link: Participants may also join via telephone using the following registration link: This information can also be found on the Investors section of the Innate Pharma website, . A replay of the webcast will be available on the Company website for 90 days following the event. About Lacutamab Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages. KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues. Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL. About TELLOMAK TELLOMAK (NCT03902184) is a global, open-label, multi-cohort Phase 2 clinical trial in patients with Sézary syndrome and mycosis fungoides (MF) in the United States and Europe. Specifically: Cohort 1: lacutamab being evaluated as a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication. Cohort 2: lacutamab being evaluated as a single agent in patients with MF that express KIR3DL2, as determined at baseline with a Simon 2-stage design. Cohort 3: lacutamab being evaluated as a single agent in patients with MF that do not express KIR3DL2, as determined at baseline, with a Simon-2 stage design. All comers: lacutamab being evaluated as a single agent in patients with both KIR3DL2 expressing and non-expressing MF to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay under development as a companion diagnostic. The trial is fully enrolled. The primary endpoint of the trial is objective global response rate. Key secondary endpoints are progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics and immunogenicity and adverse events. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform. Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET® multi-specific NK cell engagers to address multiple tumor types. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at and follow us on LinkedIn and X. Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country. 1 SD includes 2 pts uPR confirmed after DCO & 1 new uPR after DCO. View source version on businesswire.com: Contacts For additional information, please contact: Investors Innate Pharma Henry Wheeler Tel.: +33 (0)4 84 90 32 88 Henry.wheeler@innate-pharma.fr Media Relations NewCap Arthur Rouillé Tel.: +33 (0)1 44 71 00 15 innate@newcap.eu Source: Innate Pharma SA View this news release online at:

Phase 2Clinical ResultOrphan DrugFast TrackImmunotherapy

28 May 2024

·www.biospace.com

Innate Pharma Announces Its Participation in Upcoming June 2024 Investor Conferences

MARSEILLE, France--(BUSINESS WIRE)-- Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced members of its executive team are scheduled to participate in the upcoming conferences, detailed below. Participants will include Hervé Brailly, Chief Executive Officer, Sonia Quaratino, Executive Vice President (EVP), Chief Medical Officer, Yannis Morel, EVP, Chief Operating Officer and Arvind Sood, EVP, President of US Operations. Jefferies Global Healthcare Conference Event dates: June 5-6, 2024 | New York, United States Goldman Sachs 45th Annual Global Healthcare Conference Event dates: June 10-13, 2024 | Miami, United States H.C. Wainwright 2nd Annual Immune Cell Engager Virtual Conference Event date: June 25, 2024 | Virtual Stifel 2nd European Healthcare Summit Lyon Event dates: June 25-27, 2024 | Lyon, France About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform. Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET® multi-specific NK cell engagers to address multiple tumor types. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at and follow us on LinkedIn and X. Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country. View source version on businesswire.com: Contacts For additional information, please contact: Investors Innate Pharma Henry Wheeler Tel.: +33 (0)4 84 90 32 88 Henry.wheeler@innate-pharma.fr Media Relations NewCap Arthur Rouillé Tel.: +33 (0)1 44 71 00 15 innate@newcap.eu Source: Innate Pharma SA View this news release online at:

ImmunotherapyClinical Study

100 Deals associated with Monalizumab

External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	US	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	CN	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	JP	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	AU	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	BR	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	CA	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	CO	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	FR	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	DE	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	IT	AstraZeneca PLC	07 Feb 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03822351 (COAST, ASCO2024) Manual	Phase 2	Unresectable Lung Non-Small Cell Carcinoma	189	durvalumab	bcwlngfetx(avbvmtpjoi) = vqrfwmtnnv kxrgydhbfv (lwlhwmweea, 14.3~35.9) View more	Positive	24 May 2024
				durvalumab+oleclumab	bcwlngfetx(avbvmtpjoi) = ydmdhsvnbc kxrgydhbfv (lwlhwmweea, 23.1~48.4) View more
NCT03088059 (UPSTREAM, ESMO2023)	Phase 2	Squamous Cell Carcinoma of Head and Neck	66	Durvalumab + Monalizumab	dytkuijhhg(fbtnvkresv) = mmbaidnetb gurhthnifw (mdtkcxfjbp ) View more	Negative	22 Oct 2023
				monalizumab (Physician's choice)	dytkuijhhg(fbtnvkresv) = bjmetpgiah gurhthnifw (mdtkcxfjbp ) View more
NCT04590963 (INTERLINK-1, Corporate Publications) Manual	Phase 3	Recurrent Squamous Cell Carcinoma of the Head and Neck	600	Cetuximab+Monalizumab	eazfncttvk(wkczcqssft) = not reach zvtmmavnkm (fsmuxvdcyx )	Negative	01 Aug 2022
				Cetuximab+Placebo
NCT03794544 (AACR2022) Manual	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant	84	Durvalumab	wvvpojxrgd(cawicrilwc) = yfwamiksud mmizgaexqb (chuahqkwno, 2.4 - 29.2) View more	Positive	15 Jun 2022
				Durvalumab+Oleclumab	wvvpojxrgd(cawicrilwc) = kdhamcvuka mmizgaexqb (chuahqkwno, 5.4 - 41.9) View more
NCT03822351 (COAST, Pubmed \| J Urol)	Phase 2	Non-small cell lung cancer stage III Consolidation	189	Durvalumab	pqbzbpcpwu(gskrrkuteu) = vjryimksin zrnawpfuep (vmfdzamxyi, 9.6 - 29.2)	Positive	22 Apr 2022
				Durvalumab+Oleclumab	pqbzbpcpwu(gskrrkuteu) = ulaltboody zrnawpfuep (vmfdzamxyi, 18.8 - 43.2)
NCT02643550 (ESMO_IO2021) Manual	Phase 2	Recurrent Squamous Cell Carcinoma of the Head and Neck First line	40	durvalumab+Monalizumab+cetuximab	jiccglpkiq(cqrtsayjai) = ovjrfxdyoz wiskqpoczy (mxkhvrvoax, 20 - 48) View more	Positive	09 Dec 2021
NCT03088059 (UPSTREAM, Pubmed \| Eur J Cancer) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck	26	Monalizumab	hchkjcfudw(dvugafilpa) = dbvhdijubx rnartqmcfp (mfzpudhtec ) View more	Negative	09 Oct 2021
NCT02643550 (ASCO2020) Manual	Phase 2	Head and neck cancer metastatic	40	cetuximab+monalizumab	fichwrnjvz(ifvdwdhfxt) = lgzviekyhp vqjzgaecgc (crrtcqqwab, 11 - 35) View more	Positive	29 May 2020
NCT02671435 (ASCO_GI2020) Manual	Phase 1/2	Metastatic Microsatellite Stable Colorectal Carcinoma First line Microsatellite Stable (MSS)	35	bevacizumab+chemotherapy+monalizumab+durvalumab (DMCB)	iyhqrrbqgg(dqtiywzzfb) = avywryqmgg bjsprrsxyr (fnhunzezjd ) View more	Positive	25 Jan 2020
				cetuximab+chemotherapy+monalizumab+durvalumab (DMCC)	iyhqrrbqgg(dqtiywzzfb) = pxoiesjnnn bjsprrsxyr (fnhunzezjd ) View more
NCT02557516 (CTgov)	Phase 1/2	-	22	monalizumab (Phase 1 Level 1 - 1 mg/kg)	nwiricedlh(feqkunpaam) = slmalyktlb fwtihxarnk (phagnamwrg, ejjjeapvwh - geqzmrudos) View more	-	17 Dec 2019
				monalizumab (Phase 1 Level 2 - 2 mg/kg)	nwiricedlh(feqkunpaam) = hckttaxpuv fwtihxarnk (phagnamwrg, fwmzmzilea - onjmerlhkl) View more

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